Recall Z-0498-2019 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed
Stryker Sustainability Solutions
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator that has a blunt plastic tip that gently moves aside any internal viscera that may
| Date | Jun 19, 2018 |
| Status | Terminated |
| Reason | Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall execution activities initially performed by distributor. |
| Root cause | Other |
| Action | On June 29, 2018, the firm emailed an Urgent Medical Device Recall Notification to customers informing them that the firm is voluntarily recalling specific lots of the reprocessed Xcel blunt tip trocar, item number H12LP that were previously recalled under Product Field Action Z-0765-2017 initiated on 11/2/16. It has been identified through complaints that recalled product was actively distributed within the O&M network after initiation of Product Field Action Z-0765-2017. PLEASE DISTRIBUTE THIS INFORMATION TO ALL PERSONNEL RESPONSIBLE FOR REPROCESSED H12LP XCEL BLUNT TIP TROCAR. Item No: H12 |
| Quantity | 4848 |
| Distribution | US nationwide distribution in the states of OK, GA, NJ, TX, IA, CO, TX, CA, LA, PA, VA, MD, WA, and IL. OUS: None. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062497 | REPROCESSED TROCARS Ascent Healthcare Solutions, Jan 31, 2007 |